Internal Audits

Gap analysis, to determine your extent of compliance. We can combine a gap analysis with a comprehensive risk assessment to determine your current risks of non-compliance and provide a pathway to compliance that is prioritized by risk.

Routine periodic audits of quality systems.

External and Supplier Audits

For supplier qualification and due-diligence purposes, we’ve audited the following types of operations:

Manufacturers of APIs, biologics, and device and diagnostic components, both within and ex-US

Contract Manufacturing Organizations, including those for production of biologics, injectables, solid dosage forms, devices, and diagnostics